Subject: fsb's in pharmaceutical clinical trials
From: "Chris Maeda" <chrismaeda@comcast.net>
Date: Fri, 24 Dec 2004 14:24:49 -0500

 Fri, 24 Dec 2004 14:24:49 -0500
Apropos of software in pharmaceutical research, here are some pointers to
fsb's and other open source efforts in pharmaceutical research.

For clinical research (research involving human subjects), there are 2
companies developing open source data capture technology -- Phosco
(http://www.phosco.com) and Visitrial (http://visitrial.com).  (I'm the
founder of Visitrial.)  Phosco's license is free for some users, not free
for others, so it is not strictly an OSI-compatible license.  Visitrial uses
the Sleepycat/MySQL dual licensing model.  On the other hand, Phosco has
customers and revenue while Visitrial is still trying to build out the
technology.  

One of the critical issues for vendors in this space is system validation --
the regulatory agencies (FDA in the US) require trial sponsors to perform
rigorous testing on their information systems to ensure the integrity of the
data.  For close-source vendors, this means the buyers must audit the QA
processes of the vendors and perform their own internal tests.  For open
source vendors, we are hoping to make this faster and cheaper by releasing
automated test tools along with the technology that can be used for
validation.

For downstream data management and analysis, there are no open source
vendors that I am aware of.  The US National Cancer Inst. has a large open
source effort to develop standard infrastructure for their network of cancer
centers: http://cabig.nci.nih.gov.  Also, the open source R statistical
software has the potential to displace SAS as the de facto standard analysis
software but it's unlikely to happen anytime soon.

Upstream of clinical research, there is a lot of open source work in drug
discovery; the human genome work is an example of this.
http://bioinformatics.org is a good place to start to learn more about this.


-Chris

-----Original Message-----
From: Taran Rampersad [mailto:cnd@knowprose.com] 
 
David N. Welton wrote:
>Russell Nelson <nelson@crynwr.com> writes:
>
>>So will there be a "Free Drug Business" mailing list sometime?  Yes,
>>I believe so, and they'll have to face many of the same problems we
>>have faced and will face.
>>    
>I would posit that the percentage of computer programs that are in a
>position to kill people is much smaller than the position of
>pharmaceuticals in a position to kill people.
>  
And I could posit that a small percentage of computer programs are in a
position to increase or decrease the percentage of pharmaceuticals in a
position to kill people.